Thrombosis
Conditions
Brief summary
Access the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy Japanese participants after multiple doses are administered.
Interventions
DRUGBMS-986177
Oral Suspension
OTHERMatched Placebo
Oral Suspension
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants must be first-generation Japanese (born in Japan and not living outside of Japan for \> 10 years; both parents must be ethnically Japanese) * Body Mass Index 18.0 to 25.0 kg/m2, inclusive * Women must not be of nonchildbearing potential (cannot become pregnant)
Exclusion criteria
* Any significant acute or chronic medical illness * History of allergy to BMS-986177 or other factor Xia inhibitors and/or formulation excipients or history of any significant drug allergy (such as anaphylaxis or hepatotoxicity) * History or evidence of abnormal bleeding or coagulation disorder Other protocol defined inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Death | 30 days after last dose | Measured by investigator assessment |
| Incidence of Serious Adverse Events (SAEs) | 30 days after last dose | Measured by investigator assessment |
| Incidence of Adverse Events (AEs) Leading to Discontinuation of Study Therapy | 17 days | Measured by investigator assessment |
| Incidence of Adverse Events (AEs) Resulting in Clinically Significant Bleeding | 17 days | Measured by investigator assessment |
| Changes in Vital Signs (heart rate, systolic blood pressure, diastolic blood pressure, respiration rate, and temperature) | 17 days | Measured by investigator assessment |
| Change from baseline in electrocardiogram findings (ECGs) | 17 days | Measured by investigator assessment |
Countries
United States
Outcome results
None listed